NCT00193505已完成2 期
Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- complete response rate
研究概览
简要总结
In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.
详细描述
Upon determination of eligibility, patients will receive:
- Ifosfamide + Carboplatin + Etoposide + Rituximab
Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma
- •Persistent lymphoma after one or two previous chemotherapy regimens
- •Patients should not be considered candidates for high-dose chemotherapy
- •Ability to perform activities of daily living with assistance
- •Measurable or evaluable disease
- •Age > 18 years
- •Adequate bone marrow, liver and kidney function
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Patients with impaired bone marrow reserve
- •Female patients who are pregnant or lactating
- •Serious active infection at the time of treatment
- •Any other serious underlying condition
- •Brain or meningeal) with lymphoma
- •HIV or AIDS-related lymphoma
- •Received external beam radiation therapy to > 25% of active bone marrow.
- •History of other cancers, either active or treated
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
complete response rate
次要结局
- progression-free survival
- overall survival
研究者
研究点 (2)
Loading locations...
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